Acute Bronchitis
Conditions
Brief summary
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
Interventions
DRUGAGS (Experimental)
tid
DRUGAGU (Active Comparator)
tid
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Both gender, 19 years ≤ age ≤ 75 years * BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit) * Patients without fever based on Visit 2(Randomized Visit) * Those who can comply with the requirements of clinical trials * Written consent voluntarily to participate in this clinical trial
Exclusion criteria
* Patients with respiratory and systemic infections requiring systemic antibiotic therapy * Patients with bleeding tendency or coagulation disorder * Patients who investigators determines to severe respiratory disease that would interfere with study assessment * Those who have participated in other clinical trials within 4 weeks before participating in clinical trials * In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2 | Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day) | The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales/rhonchi on auscultation, chest pain during coughing, and dyspnea. These symptoms are each assessed according to a 5-point scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe |
Secondary
| Measure | Time frame |
|---|---|
| Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2 | 7days |
| Treatment response rate at Visit 3 | 7days |
| Integrative Medicine Outcome Scale (IMOS) | 7days |
| Integrative Medicine Patient Satisfaction Scale (IMPSS) | 7days |
Countries
South Korea
Outcome results
None listed